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Consultant, Senior Medical Writer
Ividata Life SciencesSenior Medical Writer at IVIDATA Life Sciences transforming complex data into clear reports. Collaborating with healthcare experts to ensure compliance and high-quality documentation.
About the role
Key responsibilities & impact- Draft clinical study report lay summaries (CSR lay summaries) and protocol synopses in plain language
- Convert complex scientific and statistical data into accessible, neutral patient-facing content (CSR, protocols, statistical outputs)
- Ensure deliverables comply with European regulatory requirements (EU CTR 536/2014) and the CTIS portal
- Coordinate review cycles and approvals with subject-matter experts (Clinical, Biostatistics, PV, Regulatory)
- Manage document scheduling and maintain strict version control to ensure publication deadlines are met
- Ensure terminological consistency and the scientific quality of documents intended for the institutional website
- Lead assessment of timeline-related risks and propose mitigation plans during periods of high activity
Requirements
What you’ll need- Advanced scientific degree (Master's, PhD or PharmD)
- Minimum 5 years' experience in medical writing within the pharmaceutical industry or a CRO
- Proven expertise in plain language writing
- Familiarity with document management systems (EDMS) preferred
- Excellent command of Microsoft Office
- Strong knowledge of EU CTR / CTIS requirements
- Excellent ability to interpret clinical study reports (CSR) and safety data
- Highly autonomous, rigorous, with excellent multi-stakeholder coordination skills and a patient-centric approach
- Fluent English required (all writing is in English)
Benefits
Comp & perks- Stimulating environment
- High-impact assignments
- Human-centered values
ATS Keywords
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Hard Skills & Tools
medical writingplain language writingclinical study report (CSR) interpretationstatistical data conversiondocument version controlrisk assessmentmitigation planning
Soft Skills
autonomyrigormulti-stakeholder coordinationpatient-centric approach
Certifications
advanced scientific degree (Master's, PhD, PharmD)